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Phase I trial of gemcitabine and CPT-11 given weekly for four weeks every six weeks
- Source :
- Annals of oncology : official journal of the European Society for Medical Oncology. 12(5)
- Publication Year :
- 2001
-
Abstract
- Our previous studies have shown that the in vitro cytotoxicity of gemcitabine and SN-38, the active metabolite of irinotecan (CPT-11), is synergistic in human tumor cell lines.Twenty-four patients with solid tumors, refractory to standard chemotherapy or for whom no effective therapy existed (age range 31-74; 7 female, 17 male; ECOG PS 0 = 12, 1 = 11, 2 = 1), received gemcitabine and CPT-11 weekly for four weeks out of every six weeks. Fifty courses of treatment (median 2, range 1-8) were given through five dose levels of gemcitabine/CPT-11 (600/75, 800/75, 800/100, 1000/100, 1000/125 mg/m2).Grade 3 and 4 neutropenia occurred in eight and two patients, respectively. Grade 3 and 4 thrombocytopenia occurred in one and three patients, respectively. Hematologic toxicity resulted inor = 2 missed doses of treatment in two out of six patients and was therefore dose limiting at gemcitabine 1000 mg/m2 and CPT-11 125 mg/m2. Grade 3 and 4 diarrhea occurred in two and one patients, respectively. Other moderate non-hematologic toxicities included alopecia, anorexia, fatigue, nausea, vomiting, and weight loss.The maximum tolerated dose for this study recommended for phase II testing is gemcitabine 1000 mg/m2 and CPT-11 100 mg/m2. A partial response was seen in transitional cell carcinoma.
- Subjects :
- Adult
Diarrhea
Male
medicine.medical_specialty
Neutropenia
Nausea
medicine.medical_treatment
Phases of clinical research
Irinotecan
Gastroenterology
Deoxycytidine
Weight loss
Internal medicine
Neoplasms
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Infusions, Intravenous
Aged
Chemotherapy
Dose-Response Relationship, Drug
business.industry
Hematology
Middle Aged
Thrombocytopenia
Gemcitabine
Surgery
Oncology
Toxicity
Vomiting
Camptothecin
Female
medicine.symptom
Every Six Weeks
business
medicine.drug
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 12
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Accession number :
- edsair.doi.dedup.....57e8a77aa1b67699de5559f7a0c37d99